Will the Vaccine Work?Questions Over Defense Department Assertions on Anthrax

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Sheri

For more info on the anthrax vaccine fiasco and murder of military -

To visit Dr. Meryl Nass's web site, go to: http://www.anthraxvaccine.org

Our Anthrax information web site: http://www.dallasnw.quik.com/cyberella/

PETITION TO OVERTURN/REPEAL FERES DOCTRINE http://www.i-charity.net/ptn/80

To visit Dr. Meryl Nass's web site, go to: http://www.anthraxvaccine.org

Tom Colosimo's website: http://www.tomcolosimo.com

Also visit: http://www.MajorBates.com/ and http://www.enter.net/~jfsorg/

Anthrax Vaccine Network http://www.anthraxvaccine.net

Sgt. Larson's story

http://stripes.com/servlet/News/ViewArticle?articleId=100036895

http://www.house.gov/reform/hearings/healthcare/00.10.03/accountability.doc

http://www.jamesmadisonproject.org/importantlinks.html

http://www.nccn.net/~wwithin/anthrax.htm

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Will the Vaccine Work?

Questions Over Defense Department Assertions on Anthrax

Commentary

By Regush

Oct. 8

— How credible is the claim made by the Defense Department that anthrax

vaccine is effective for use against inhaled anthrax?

MORE ON THIS STORY

FULL COVERAGE

• Biological and Chemical Weapons: Full Coverage

• America Attacked

• Archive: Read past Second Opinion columns

This is an important question given the high stakes. The Department informs

us in its latest official written update on the vaccine, dated Aug. 15,

that, for example, up to an estimated 3 million deaths could result from

aerosolized release of 100 kg (220 pounds) of anthrax spores upwind of the

Washington, D.C., area.

Anthrax, which is colorless, odorless and tasteless, does not spread

person-to-person. The bacterium's spores can be spread in the air. One deep

breath, which could mean inhaling many thousands of spores, can be fatal,

if antibiotics are not taken before symptoms develop.

And, of course, the biological warfare, or BW, threat to U.S. forces is

considerable. " At least seven countries, including several hostile to

Western democracies — Iran, Iraq, Libya and North Korea — now possess or

are pursuing offensive BW capabilities, " according to the report.

Questions on Giving It Out

Since March 1998, about 1 million doses of anthrax vaccine have been given

to about 520,000 service members. But there is now a vaccine shortage, and

vaccination in the military has greatly slowed down.

Meanwhile, critics of the vaccine have raised many questions about its

safety. More than 400 members of the military have either quit or faced

court-martial rather than take the anthrax vaccine for fear of side effects

reported, such as extreme fatigue, headaches, muscular problems and insomnia.

In any case, the Food and Drug Administration (FDA) has blocked release of

vaccine produced at the BioPort Corporation in Lansing, Mich., because

there have been a series of problems at the manufacturing plant, including

contamination of lots of the vaccine and questions surrounding the

company's quality assurance records.

The company plans to ask the FDA to license a new manufacturing facility.

On its Web site, BioPort says it " remains on track to meet target dates for

submissions to the FDA for the company's renovated anthrax vaccine

manufacturing facilities. Once approval for the facility is obtained [from

the FDA], BioPort will continue to deliver on its obligation to meet the

needs of the Department of Defense for the protection of the men and women

in our armed service. "

The Defense Department (DoD) says in its report that the company has

addressed the FDA's concerns.

Until the FDA approves additional anthrax vaccine, the small amounts still

available for use will be designated for special mission units and

research, according to the DoD.

Full vaccination against anthrax is said to occur after six doses are given

over 18 months. Yearly boosters are also required.

Since Sept. 11, the DoD and BioPort have been receiving requests from

civilians for the vaccine.

What’s the Science?

But should the vaccine be made commercially available one day, what would

its value be against an anthrax attack? I, for one, would want to feel

convinced that the vaccine works, that any claims for the vaccine's

efficacy are based on solid science.

The DoD states: " The evidence of vaccine effectiveness against aerosol

exposure to anthrax spores is persuasive, based on both human and animal

studies. "

But let's look more closely.

First the key research on animals. Some of the data come from experiments

on immunity with thousands of guinea pigs. Research on guinea pigs also

focuses, among other things, on determining the vaccine's potency. In other

words, guinea pigs are considered important for tests on efficacy.

So, taking all the available data into account, after being immunized with

the anthrax vaccine, how many guinea pigs survive after being " challenged "

with anthrax?

Overall, depending on the natural-occurring (as opposed to genetically

manipulated) strains of anthrax that were used, survival rates in several

studies varied from 23 percent to 71 percent when the guinea pigs inhaled

the anthrax. (The range is wide most likely at least in part because

different strains were tested.)

This is hardly persuasive evidence of efficacy. Rather, the data point to

moderate protection.

But let's carry on with non-human primates, particularly Rhesus monkeys,

which the DoD report says are the animals " that best mimic humans for

inhalational anthrax. "

The DoD refers to five studies of Rhesus monkeys given one or two doses of

the vaccine. The overall results show that " 62 of 65 vaccinated monkeys

survived lethal aerosol challenge with hundreds of times the median fatal

dose. " That's 95 percent protection. And, " in these studies, 18

unvaccinated monkeys were challenged and all died. "

Now that's impressive. Actually, quite spectacular. But let's look more

closely at what the military has often claimed, particularly at

congressional hearings, are its best data supporting the vaccine's ability

to fight off aerosolized anthrax.

For example, two monkey studies, important to the overall data and

conducted at the U.S. Army Medical Research Institute of Infectious

Diseases at Fort Detrick, Md., were brief reports presented at

international meetings.

These types of conference reports, which are sometimes run as supplements

to a medical bulletin or journal, are typically thought of by scientists as

brief presentations of research findings. They were published in a

little-known bulletin (the Salisbury Medical Bulletin-Special Supplement

no.87 in 1996).

Monkey Tests

This doesn't necessarily mean that the science is poorly conducted, but it

might well be. How do you know unless the research undergoes careful

scrutiny? This raises a red flag, considering that the data from these

reports are being used as part of a scientific package of information in a

high-stakes situation for declarations about the vaccine's efficacy.

And another question must be asked about the monkey studies: Can the data

be extrapolated to humans?

One reason for pointing to the Rhesus monkey as a good mimic for humans is

that there is evidence that pathological findings in the lungs infected by

anthrax in both monkeys and humans are similar. But is that enough to go on?

Maybe not. Let's zero in on the conclusion of one of the brief reports

itself. Here the authors are discussing the difference between partial

protection from the vaccine in guinea pigs and the high level of efficacy

in rhesus monkeys.

The authors conclude: " These findings suggest the importance of various,

specific immune mechanisms against inhalation anthrax may vary in different

animal species, or that the ability of the licensed human anthrax vaccine

to stimulate cell-mediated immunity may be greater in some species than

others. "

There is also no method available today to compare the immune responses of

Rhesus monkeys to an anthrax vaccine with those of humans. What is needed

is what is termed a " marker, " some signal in the immune defense process

that is similar to both species.

In April 1999, Dr. Kwai-Cheung Chan, then Director of Special Studies and

Evaluations (National Security and International Affairs Division) of the

United States Government Accounting Office (GAO) had this to say to a

congressional committee investigating the anthrax vaccine: " Taking all the

evidence into account, it's likely that the vaccine does give some

protection, but to what extent, against what amount of anthrax, against

which strains and how long protection lasts, are not known. "

Other Considerations

And speaking about strains, there is the issue of whether an attack from

anthrax might involve a genetically engineered strain that the vaccine

cannot fight. Here we find ourselves in the realm of the Great Unknown.

We have to also keep in mind that animal tests run in a lab do not mimic

battlefield conditions or those that might occur should a bio-war target be

a civilian population, for the reasons that the GAO's Chan cited.

Now we come to the efficacy data on humans — really just one controlled

study that is often cited by the military as suggestive evidence that the

vaccine works against aerosolized anthrax. And this is the research that

led to approval of the vaccine by the FDA in 1970.

The study involved vaccinating 149 mill workers who in those days were in

danger of being exposed via the skin to anthrax in animal products. No one

developed anthrax. And of the 448 people at the mill who were left

unvaccinated, five cases of inhalation anthrax occurred..

But even the DoD report indicates that, " despite the obvious trend, the

number of cases of inhalation anthrax are too small for the difference

between groups to be statistically conclusive by itself. " The DoD refers to

a " follow-up " by the Centers of Disease Control and Prevention which

further suggests the vaccine worked — but here again, it's more indicative

of a trend than hard scientific evidence.

When all is said and done, what we now essentially have is a hodge-podge of

data about efficacy, ranging from the almost irrelevant to the modest —

data that does not reassure me on scientific grounds that the vaccine is

effective.

Reason for Hope, or Not?

I can understand the DoD's strong feelings: " The consequences of

unvaccinated Service Members becoming biological warfare casualties would

be tragic enough, but the consequences would be graver than their deaths

alone. Their individual deaths may jeopardize the capability and survival

of entire military units, as well as the success of the military mission. "

But we need a vaccine based solidly on good and detailed science — and not

one based on hope and apparent desperation.

And, given the difficulties that are all too apparent in developing a

vaccine that would protect against a weaponized attack of anthrax (likely

one involving a genetically altered form of the bacterium and one that

could easily be changed), it might also make a ton of sense to start

thinking about other methods to prevent anthrax-related tragedies.

Congress should hold hearings on what some of those other methods might be

and also on the need for research to better understand how an anthrax

infection develops in the body. It also might be valuable to spend some tax

dollars on figuring out ways to stop the infection once it occurs. Better

late than never.

Regush produces medical features for ABCNEWS. In his regularly

featured column, he investigates medical trouble spots, heralds innovative

achievements and analyzes health trends. His own website is

regush.com.

--------------------------------------------------------

Sheri Nakken, R.N., MA

Vaccination Information & Choice Network, Nevada City CA & UK

530-740-0561 Voicemail in US

http://www.nccn.net/~wwithin/vaccine.htm

" All that is necessary for the triumph of evil is that good men ( &

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